Medtronic's CoreValve system was as safe as Edward Lifesciences' Sapien valve when both long and short-term death rates were compared.

Action Points

Note that there was no difference in mortality among patients who received either a CoreValve or Sapien transcutaneous aortic valve placement in this observational cohort study.

Be aware that of the 793 patients receiving valves, only 408 were included in this study due to the limitations of propensity-score matching.

Two aortic valves for percutaneous implantation had similar rates of complications and death when introduced transfemorally, researchers found.

All-cause mortality at 30 days was 8.8% for the CoreValve and 6.4% for the Sapien (P=0.352), reported Antonio Colombo, MD, of the San Raffaele Scientific Institute in Milan, Italy, and colleagues.

Cardiovascular mortality at 30 days also was not statistically different: 6.9% versus 6.4% for CoreValve and Sapien, respectively, they wrote in a paper published online by the Journal of the American College of Cardiology.

At 1 year, Colombo and colleagues also found no differences in the rate of all-cause death between the CoreValve and Sapien groups (16.3% versus 12.3%, P=0.266) or in the rate of cardiovascular death (8.3% versus 7.4%, P=0.713).

In addition, there was no difference in the combined safety and efficacy endpoints at 30 days and 1 year between the two valves. This included rates of myocardial infarction, stroke, major vascular complications, or life-threatening bleeding.

The 2.6% incidence of stroke seen in this study "seems acceptable compared with previous experience," they wrote.

Strokes appeared to be more related to valve embolization. In fact, the center with the highest rate of stroke had an embolization rate of 10.4%.

"It is possible that the process of recapturing and the subsequent retrieval of the valve and delivery system through the aorta could have played a role [in causing stroke]," they suggested.

As expected, researchers said, there was a greater need for permanent pacemakers in the CoreValve group.

A study published in August 2012, however, found no significant adverse effect on clinical outcomes related to the implantation of a pacemaker among patients undergoing TAVI.

Also of importance was a similar rate of the incidence of aortic regurgitation of any grade between the two devices; however, the current study confirms that "moderate/severe aortic regurgitation is associated with increased 1-year mortality," they said.

The study was nonrandomized and retrospective, which can result in potential selection bias and confounding. Other limitations included the lack of a central core laboratory and the inability to assess valve durability because of the short follow-up.

The CoreValve is made by Medtronic and the Sapien valve is made by Edwards Lifesciences.

Colombo and several other authors had no conflicts of interest to declare. Tchetche, Dumonteil, and Marcheix are proctors for Edwards Lifesciences and Medtronic; de Jaegere is a proctor for Medtronic; Latib is on the Medtronic Advisory Board.

Reviewed by F. Perry Wilson, MD, MSCE Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner